Consultancy for Global Quality and Compliance
Elite Quality and Regulatory Support
SV-01
Independent Vendor & Facility Audits
Certified Auditor with 500+ vendor audits completed across Contract Manufacturing Sites in India. We assess your facility against cGMP, Schedule M, and ICH standards before regulators do.
SV-02
Regulatory Audit Readiness (US FDA / EU / WHO)
Direct, hands-on experience preparing sites for and facing US FDA, EU, WHO Geneva, MHRA, and TGA inspections — including audits completed with zero major observations.
SV-03
CAPA & Quality Systems Implementation
End-to-end quality management systems, CAPA programs, and deviation/OOS investigation frameworks built and led across formulation, API, and sterile manufacturing sites.
SV-04
SOP Development
Bespoke training programs and standard operating procedure creation to integrate a high-level culture of quality assurance.
SV-05
System Validations
Professional support for validation lifecycles, full equipment qualification, and data integrity to uphold operational standards.
SV-06
Chain Risk Analysis
Strategic management of worldwide supply networks, featuring vendor audits and GDP adherence for cold-chain logistic distribution.
Elite Quality Assurance Mastery
With 29+ years of GxP leadership, he has led teams of 300, audited 500+ vendors, and successfully managed high-stakes audits from the US FDA, EU, WHO, MHRA, and TGA.
Soumen Bose
Founder
Verified Expertise
A testament to our dedication to excellence through successful global compliance results and thriving franchise operations.
“
The team helped us achieve flawless audit results across our international sites. Their precision is standard-setting in the modern pharmaceutical landscape.
The franchise growth sparked by Soumen Bose in Vadodara, India, allowed us to expand into new markets without facing a single regulatory or compliance barrier.
Expert advisory that drives real financial growth. Their compliance framework is now the foundation of our entire international quality management operation.
29 Years in Pharmaceutical QA Leadership
Reach out to soumenbose9971@gmail.com or call +91 98166 14393 for verified guidance on meeting strict regulatory targets.